ADHDNCT01659164
Psychological Treatment for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing Group treatment for adults with ADHD in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to build relational skills, skills in organizing and structuring everyday life, handle difficult emotions and impulses etc. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- Group treatment for adults with ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * Clinical diagnosis of AD/HD
- * Age 18-65
- 17 or more on the Adult ADHD Self Report Scale (ASRS v1.1)
- Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant.
- No change in any other medical treatment is anticipated during the study time frame for the participant.
- Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
- The participant hasn´t used drugs the last 3 months.
Who cannot join
- Diagnosed substance abuse according to DSM-IV criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
- Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
- IQ ≤70 according to a neuropsychological assessment
- * Suicidality risk which is assessed during the first assessment interview.
- Organic brain syndrome
- Serious somatic condition which will unable the participant to participate (through the training protocol)or, is anticipated to have a negative impact on the treatment results
Show all 9Show fewer
- Autism spectrum disorder (severe)
- Severe depression
- Other current psychological treatment for AD/HD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) - Pilot Evaluation of a New Treatment Manual Based on CBT and DBT
The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to build relational skills, skills in organizing and structuring everyday life, handle difficult emotions and impulses etc. The treatment will be in a group format and it is hypothesized that the psychological intervention will result in reduced ADHD symptoms and to decreased experience of stress and depressive symptoms. The uncontrolled design does not allow for any causal inferences from the results, this pilot study is primarily to be seen as a preparation before a subsequent RCT.
Read the detailed description
Approximately one-third of children with ADHD continue to be fully symptomatic into adulthood and many of the remainders often retain some residual problems that require treatment. Thus ADHD is a prevalent and chronic disabling disorder. Drugs provide first line treatment for adults with ADHD but are not enough for everybody, while we still lack proper evidence for promising psychological treatment. In addition to core symptoms of ADHD including regulatory difficulties of attention, activity level and impulses, difficulties with emotional regulation are common.
Follow-up studies of adults with ADHD have shown that only a few patients were offered sufficient treatment and support after the neuropsychiatric assessment and testing. The majority of adults diagnosed with ADHD are offered pharmacological treatment (stimulant medication) as the sole treatment. However, stimulant medication is not effective for up to 20-50 percent of adults as they may not experience symptom reduction or they are unable to tolerate the medication.
Consequently, the possible benefits of identifying and treating individuals with ADHD are extensive. Treatment of ADHD is preferably multimodal, i.e. consisting of more than one intervention.
There has been limited research to date concerning psychosocial treatments for adult ADHD. Studies of cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) show that structured short-term therapies are promising in reducing ADHD related symptoms and increasing life quality. Focus in the CBT treatment is to build skills, increasing and compensating for deficits in the executive functioning due to impairments of the frontal lobe. DBT combines change-oriented skills from CBT with acceptance-oriented skills and core mindfulness skills. DBT skills have been tried out and validated as a promising intervention package for adults with ADHD through the research of Steven Safren and Bernd Hesslinger.
The objective of the planned study is to evaluate a new manual for group treatment, with a combination of treatment methods from Safrens and Hesslingers evidence-based treatment manuals. The aim of the pilot project is to create a clinically effective combination of the different methods of treatment, with a high degree of understanding, acceptance, use and perceived usefulness of the patients undergoing treatment. Both qualitative and quantitative data about patients' perceptions and use of the different methods will be collected during and after treatment to increase knowledge of how treatments can be developed and combined in order to better match the needs of patients.
- Conditions
- ADHD
- Being tested
- Group treatment for adults with ADHD
- Keywords
- Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Group Treatment, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group treatment for adults with ADHDBehavioural
14 weeks of group treatment for adults with ADHD
| Study group | Role | What they receive |
|---|---|---|
| Group treatment (uncontrolled) | Experimental | Psychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition. Receives: Behavioral: Group treatment for adults with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in ASRS- v 1.1
ADHD Self Report Scale (self rating)
Measured: 14 weeks (post)
Secondary outcomes (7)
Change (from baseline) in ADHD Rating Scale
ADHD Rating Scale - assessed by a clinician
Measured: 14 weeks (post)
Change (from baseline) in EQ-5D
Euroqol - (self report) to measure general health and quality of life
Measured: 14 weeks (post)
Change (from baseline) in ISI
Insomnia Severity Index - (self report) to measure insomnia symptoms
Measured: 14 weeks (post)
Change (from baseline) in PSS-4
Perceived Stress Scale - (self report) to measure level of stress in everyday life
Measured: 14 weeks (post)
Change (from baseline) in Sheehan Disability Scale
Sheehan Disability Scale - (self report) to measure level of disability in everyday life
Measured: 14 weeks (post)
Change (from baseline) in MADRS-S
Montgomery-Åsberg Depression Rating Scale - (self report) to measure level of depression
Measured: 14 weeks (post)
Change (from baseline) in DERS
Difficulties of Emotion Regulation Scale - (self report)
Measured: 14 weeks (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Viktor Kaldo, Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659164
- Sponsor's protocol ID
- 2012/333-31
- Status last verified
- Apr 2015
- First submitted
- 3 Aug 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) - Pilot Evaluation of a New Treatment Manual Based on CBT and DBT
- ClinicalTrials.gov ID
- NCT01659164
- Acronym / sponsor ID
- 2012/333-31
- Conditions
- ADHD
- Keywords
- Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Group Treatment, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this uncontrolled pilot study is to develop and make an initial evaluation of a new treatment manual for treatment of ADHD in adults. The objectives in the treatment is to build relational skills, skills in organizing and structuring everyday life, handle difficult emotions and impulses etc. The treatment will be in a group format and it is hypothesized that the psychological intervention will result in reduced ADHD symptoms and to decreased experience of stress and depressive symptoms. The uncontrolled design does not allow for any causal inferences from the results, this pilot study is primarily to be seen as a preparation before a subsequent RCT.
Detailed description
Approximately one-third of children with ADHD continue to be fully symptomatic into adulthood and many of the remainders often retain some residual problems that require treatment. Thus ADHD is a prevalent and chronic disabling disorder. Drugs provide first line treatment for adults with ADHD but are not enough for everybody, while we still lack proper evidence for promising psychological treatment. In addition to core symptoms of ADHD including regulatory difficulties of attention, activity level and impulses, difficulties with emotional regulation are common.
Follow-up studies of adults with ADHD have shown that only a few patients were offered sufficient treatment and support after the neuropsychiatric assessment and testing. The majority of adults diagnosed with ADHD are offered pharmacological treatment (stimulant medication) as the sole treatment. However, stimulant medication is not effective for up to 20-50 percent of adults as they may not experience symptom reduction or they are unable to tolerate the medication.
Consequently, the possible benefits of identifying and treating individuals with ADHD are extensive. Treatment of ADHD is preferably multimodal, i.e. consisting of more than one intervention.
There has been limited research to date concerning psychosocial treatments for adult ADHD. Studies of cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) show that structured short-term therapies are promising in reducing ADHD related symptoms and increasing life quality. Focus in the CBT treatment is to build skills, increasing and compensating for deficits in the executive functioning due to impairments of the frontal lobe. DBT combines change-oriented skills from CBT with acceptance-oriented skills and core mindfulness skills. DBT skills have been tried out and validated as a promising intervention package for adults with ADHD through the research of Steven Safren and Bernd Hesslinger.
The objective of the planned study is to evaluate a new manual for group treatment, with a combination of treatment methods from Safrens and Hesslingers evidence-based treatment manuals. The aim of the pilot project is to create a clinically effective combination of the different methods of treatment, with a high degree of understanding, acceptance, use and perceived usefulness of the patients undergoing treatment. Both qualitative and quantitative data about patients' perceptions and use of the different methods will be collected during and after treatment to increase knowledge of how treatments can be developed and combined in order to better match the needs of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group treatment (uncontrolled) | Experimental | Behavioral: Group treatment for adults with ADHDPsychological treatment in group for adults with ADHD (pilot) during 14 weeks with focus on decreasing disabilities due to the condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- * Clinical diagnosis of AD/HD
- * Age 18-65
- 17 or more on the Adult ADHD Self Report Scale (ASRS v1.1)
- Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant.
- No change in any other medical treatment is anticipated during the study time frame for the participant.
Key exclusion criteria (9 listed)
- Diagnosed substance abuse according to DSM-IV criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
- Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
- IQ ≤70 according to a neuropsychological assessment
- * Suicidality risk which is assessed during the first assessment interview.
- Organic brain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group treatment for adults with ADHD14 weeks of group treatment for adults with ADHD | Behavioural | Group treatment (uncontrolled) |
Primary outcome
Change (from baseline) in ASRS- v 1.1
Time frame: 14 weeks (post)
ADHD Self Report Scale (self rating)
7 secondary outcomes
Change (from baseline) in ADHD Rating Scale
Time frame: 14 weeks (post)
Change (from baseline) in EQ-5D
Time frame: 14 weeks (post)
Change (from baseline) in ISI
Time frame: 14 weeks (post)
Change (from baseline) in PSS-4
Time frame: 14 weeks (post)
Change (from baseline) in Sheehan Disability Scale
Time frame: 14 weeks (post)
Change (from baseline) in MADRS-S
Time frame: 14 weeks (post)
Change (from baseline) in DERS
Time frame: 14 weeks (post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Kaldo, Ph.D. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group treatment for adults with ADHD in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) in ASRS- v 1.1 (time frame: 14 weeks (post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.